L-ornithine phenyl acetate and methods of making thereof

Abstract

Disclosed herein are crystalline forms of L-ornithine phenyl acetate and methods of making the same. The crystalline form may, in some embodiments, be Forms I, II, III and V, or mixtures thereof. The crystalline forms may be formulated for treating subjects with liver disorders, such as hepatic encephalopathy. Accordingly, some embodiments include formulations and methods of administering L-ornithine phenyl acetate.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Application No. 61 / 166,676, filed April 3, 2009. The entire content of the priority document is incorporated into this specification by reference. technical field [0003] This application relates to the fields of medicinal chemistry, biochemistry and medicine. Specifically, the present application relates to L-ornithine phenylacetate, its preparation method and its use. Background technique [0004] Hyperammonemia is a hallmark of liver disease characterized by excess ammonia in the bloodstream. Hepatic encephalopathy is the major clinical consequence of progressive hyperammonemia and is a complex neuropsychiatric syndrome that can be complicated by acute or chronic liver failure. It is characterized by altered mental status and includes a wide range of neuropsychiatric syndromes, from subtle signs of altered brain function to overt psychiatric and / or neurological ...

AI Technical Summary

Problems solved by technology

Similarly, certain salts are difficult to administer intravenously due to increased osmotic pressure (i.e., the solution is hypertonic)

High concentrations of excess salt can require dilution of very large volumes of solution for intravenous administration, which in turn can lead to excessive fluid overload

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